The "Global Paradise System" Registry

Hypertension Clinical Trial

— GPS Registry  

Official title:

The "Global Paradise® System" Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05027685
• Other study ID #: CLN-0927
• Status: Recruiting
• Start date: January 13, 2022
• Est. completion date: December 31, 2031

Study information

• Verified date: July 2023
• Source: ReCor Medical, Inc.
• Contact: Helen Reeve-Stoffer, PhD
• Phone: +44 (0) 794 774 8006
• Email: hreeve-stoffer[@]recormedical.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The GPS Registry is a multi-centre, single-arm, non-interventional (observational) registry. In addition to collecting data from patients treated as per standard clinical practice, the Registry will also regularly collect telemetric Home Blood Pressure (HBP) measurements and Patient Reported Outcome (PRO) data via a standardized quality of life questionnaire. The objective of the GPS Registry is to document the long-term safety and effectiveness of the commercially available Paradise Ultrasound Renal Denervation System when used per its labelling in patients deemed to be candidates for RDN as per physician's assessment.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: December 31, 2031
• Est. primary completion date: December 31, 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Appropriately signed and dated informed consent

• Age =18 at time of consent

• Patient candidate for renal denervation with the Paradise System based on physician's assessment OR Patient treated with the Paradise Ultrasound Renal Denervation System within the 6 months prior to consent

Exclusion Criteria:

Patients who meet any of the contraindications listed in the Instructions for Use will be excluded.

The contraindications are:

• Stented renal artery

• Less than 18 years of age

• Pregnant

• Known allergy to contrast medium

• Renal arteries diameter < 3 mm and > 8 mm

• Renal artery with Fibromuscular (FMD) disease

• Renal artery aneurysm

• Renal artery stenosis of any origin >30%

• Iliac/femoral artery stenosis precluding insertion of the Paradise catheter

Related Conditions & MeSH terms

• Hypertension

Intervention

Device:
• The Paradise Ultrasound Renal Denervation System
The CE-marked and commercially available ReCor Medical Paradise Ultrasound Renal Denervation System (Paradise System) is a catheter-based device designed to use ultrasound energy to thermally ablate the nerves surrounding the renal artery and serving the kidney.

Locations

Country	Name	City	State
Belgium	OLV Ziekenhuis Aalst	Aalst
Belgium	CHU Saint Pierre Brussels	Brussel
Belgium	UCL St Luc	Brussel
France	CHU Bordeaux Hôpital St. André	Bordeaux
France	HEGP (Hôpital Européen Georges Pompidouv) Paris	Paris
France	Centre Hospitalier de Pau	Pau
Germany	Universitäts-Herzzentrum Freiburg Bad Krozingen	Bad Krozingen
Germany	Charité Universitätsmedizin Berlin Campus Benjamin Franklin	Berlin
Germany	Klinikum Coburg GmbH	Coburg
Germany	Klinikum Lippe GmbH Detmold	Detmold
Germany	Herzzentrum Dresden GmbH Universitätsklinik	Dresden
Germany	Universitätsklinikum Düsseldorf	Düsseldorf
Germany	Universitätsklinikum Erlangen	Erlangen
Germany	Cardiovasculäres Centrum (CVC) Frankfurt	Frankfurt
Germany	St. Barbara-Klinik Hamm Heessen	Hamm
Germany	University Clinic of Saarland - Homburg	Homburg
Germany	Universitätsklinikum Köln	Köln
Germany	Herzzentrum Leipzig GmbH	Leipzig
Germany	Sana Kliniken Lübeck gGmbH	Lübeck
Germany	Marienhaus Klinikum Mainz	Mainz
Germany	Detusches Herzzentrum München (DHM)	München
Germany	Robert-Bosch-Krankenhaus GmbH Stuttgart	Stuttgart
Germany	Schwarzwald-Baar Klinikum Villingen-Schwenningen	Villingen-Schwenningen
Monaco	Centre Hospitalier Princesse Grace Monaco	Monaco
Netherlands	Noordwest Ziekenhuisgroep	Alkmaar
Netherlands	Erasmus MC Rotterdam	Rotterdam
Switzerland	HUG Geneve Switzerland	Geneva
Switzerland	Heart Center Lucerne -Luzerner Kantonsspital	Luzern
United Kingdom	Royal Bournemouth Hospital, Bournemoth	Bournemouth
United Kingdom	Kent and Canterbury Hospital, Canterbury	Canterbury
United Kingdom	University Hospital Wales, Cardiff	Cardiff
United Kingdom	Queen Elizabeth Hospital, Glasgow	Glasgow
United Kingdom	Hammersmith Hospital (Imperial College Healthcare NHS Trust)	London
United Kingdom	WHRC - Barts Health, London	London
United Kingdom	Freeman Hospital, Newcastle	Newcastle

Sponsors (1)

Lead Sponsor	Collaborator
ReCor Medical, Inc.

Countries where clinical trial is conducted

Belgium,  France,  Germany,  Monaco,  Netherlands,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of all-cause mortality	Rate of mortality attributed to any causality as per site standard practice.	Through 5 Years post-procedure
Primary	Incidence of new onset end-stage renal disease	eGFR<15 mL/min/m2 or need for renal replacement therapy as per site standard practice	Through 5 Years post-procedure
Primary	Significant decline in renal function	=50% increase in serum creatinine (mg/dL)	Through 5 Years post-procedure
Primary	New renal artery stenosis	>70% confirmed by CTA/MRA as per site standard practice.	Through 5 Years post-procedure
Primary	Incidence of renal artery perforation or dissection requiring an invasive intervention		Through 5 Years post-procedure
Primary	Incidence of major vascular complications (e.g, clinically significant groin hematoma, arteriovenous fistula, pseudoaneurysm) requiring surgical repair, interventional procedure, thrombin injection, or blood transfusion as per site standard practice		Through 5 Years post-procedure
Primary	Incidence of hospitalization for hypertensive crisis or symptomatic hypotension		Through 5 Years post-procedure
Primary	Incidence of hospitalization for major cardiovascular- or hemodynamic-related events (e.g. HF; AF)		Through 5 Years post-procedure
Primary	Incidence of new onset stroke, TIA or CVA		Through 5 Years post-procedure
Primary	Incidence of acute myocardial infarction		Through 5 Years post-procedure
Primary	Incidence of any coronary revascularization		Through 5 Years post-procedure
Primary	Reduction in average home systolic/diastolic BP in mmHg as compared to enrollment		Through 5 Years post-procedure
Primary	Reduction in average office systolic/diastolic BP in mmHg as compared to enrollment		Through 5 Years post-procedure
Primary	Reduction in average ambulatory systolic/diastolic BP in mmHg (daytime, nighttime and 24-hr) as compared to enrollment		Through 5 Years post-procedure
Primary	Incidence of home systolic BP reductions of =5 mmHg, =10 mmHg, and =15 mmHg		Through 5 Years post-procedure
Primary	Incidence of office systolic BP reductions of =5 mmHg, =10 mmHg, and =15 mmHg		Through 5 Years post-procedure
Primary	Incidence of ambulatory systolic BP (daytime/24-hr/night-time) reductions of =5 mmHg, =10 mmHg, and =15 mmHg		Through 5 Years post-procedure
Primary	Percentage of subjects who are controlled according to current guidelines		Through 5 Years post-procedure
Primary	Change in office/home/ambulatory pulse pressure in mmHg		Through 5 Years post-procedure
Primary	Change in office/home/ambulatory heart rate in bpm		Through 5 Years post-procedure
Primary	Percentage of subjects without any anti-hypertensive treatment with analysis stratified by number of enrollment antihypertensive medications		Through 5 Years post-procedure
Primary	Analysis of quarterly Home BP in mmHg		Through 5 Years post-procedure
Primary	Change from enrollment in quality of life scores as measured by the 12-item Short Form Health Survey (SF-12)	The 12-item Short Form Health Survey (SF-12) is a measure of health-related quality-of-life. Scores for each domain range from 0 to 100, with a higher score indicating a more favorable health state.	Through 5 Years post-procedure